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Urinalysis Control

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref USUC00001083Model UNAMAX U11 Control、UNAMAX U14 Control

EMDN W010106020601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IUCS000015QX Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Urinalysis Control
Model / Reference
UNAMAX U11 Control、UNAMAX U14 Control, USUC00001083
Primary DI / UDI-DI
06935740753739
Basic UDI-DI
69357407IUCS000015QX
EMDN Code
W010106020601 Urine testing controls
Device Class
Class B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06935740753739|69357407IUCS000015QX 61 fields · synced 24 Oct 2026